Country Approval Specialist Job In Thermo Fisher Scientific In Mumbai

Job Description :Job Scope :Participates in the management and preparation, review and coordination of CountrySubmissions in line with global submission strategyFunctions and Responsibilities:Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC,additional special national local applications if applicable, eg gene therapy approvals, viralsafety dossiers, import license) in alignment with global submission strategy.

Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internalclients Provides project specific local SIA services and coordination of these projects May have contact with investigators for submission related activities.

Key-contact at country level for either Ethical or Regulatory submission-related activities Coordinates, under guidance, with internal functional departments to ensure various sitestart-up activities are aligned with submissions activities and mutually agreed upontimelines ensures alignment of submission process for sites and study are aligned to thecritical path for site activation.

Achieves PPD's target cycle times for site May work with the start-up CRA(s) to prepare the regulatory compliance reviewpackages, as applicable May develop country specific Patient Information Sheet/Informed Consent formdocuments.

May assist with grant budgets(s) and payment schedules negotiations with sites Supports the coordination of feasibility activities, as required, in accordance with agreedtimelines.

Entes and maintains trial status information relating to SIA activities onto PPD trackingdatabases in an accurate and timely manner Ensures the local country study files and filing processes are prepared, set up andmaintained as per PPD WPDs or applicable client SOPs Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and currentregulatory guidelines as applicable to services provided.

Qualifications - ExternalQualifications:Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job(comparable to 2+ years)Knowledge, Skills and Abilities: Effective oral and written communication skills Excellent interpersonal skills Strong attention to detail and quality of documentation.

Good negotiation skills Good computer skills and the ability to learn appropriate software Good English language and grammar skills Basic medical/therapeutic area and medical terminology knowledge Ability to work in a team environment or independently, under direction, as required.

Basic organizational and planning skills Basic knowledge of all applicable regional / national country regulatory guidelines and ECregulations

Thermo Fisher Scientific is looking for .

Thermo Fisher Scientific is looking for Any Graduate / Post Graduate profile candidates.